Senior Data Reviewer – Cell & Gene Therapy

This is a fully remote position, open to applicants in Wisconsin.

📋 Description

• Conduct intricate laboratory analyses of pharmaceutical products.

• Utilize analytical instrumentation while calculating, analyzing, and documenting data in accordance with PPD SOPs and industry standards.

• Serve as a project leader across various projects and engage with clients effectively.

• Assess and interpret data, as well as compose reports and protocols.

• Direct the scientific execution of projects and relay regulatory concerns to senior team members.

• Independently execute method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds.

• Design and conduct experiments with minimal oversight.

• Develop study protocols, project status reports, final study reports, and technical documentation.

• Relay data and technical concerns to clients, addressing their needs and inquiries.

• Mentor, instruct, and oversee laboratory activities of team members.

• Diagnose instrument and analytical issues.

• Aid in quality systems and the integration of new equipment.

• Create method validation or transfer protocols and establish project timelines.

• Review, interpret, and analyze data for technical quality and adherence to protocols, methods, SOPs, client specifications, GMP, and GLP.

• Conduct self and peer reviews of data prior to submission to QA and distribution to customers.

⛳️ Requirements

• Bachelor’s degree or equivalent with relevant formal academic/vocational qualifications.

• Over 5 years of prior experience relevant to the role.

• A combination of suitable education, training, and/or directly related experience may also be considered.

• Strong understanding of general chemistry and separation science.

• Comprehensive knowledge of laboratory requirements, PPD and client SOPs, ICH guidelines, USP standards, and FDA regulations.

• Proficient in Microsoft Excel and Word.

• Skilled with technical operating systems.

• Demonstrated problem-solving and troubleshooting skills.

• Strong verbal and written communication abilities.

• Established technical writing capabilities.

• Effective time management and project management skills.

• Ability to collaborate effectively within a team.

• Capacity to train junior personnel.

• Must possess legal authorization to work in the United States without sponsorship.

• Must successfully pass a comprehensive background check, including drug screening.

• Capable of communicating, receiving, and comprehending information and ideas with diverse groups.

• Able to work upright and stationary and/or stand for typical working hours.

• Capable of lifting and moving objects weighing up to 25 pounds.

• Able to function in non-traditional work environments.

• Proficient in using and learning standard office equipment and technology.

• May encounter potentially hazardous elements, including infectious agents.

• Able to perform successfully under pressure while managing multiple projects or activities.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.

• Resources for career development and support for individual career goals.

• Opportunities for training and mentoring.

• Global impact through life-changing therapies and clinical research.

• Support for a healthy and balanced work environment.